MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD TLA INSTRUMENT SYSTEM; MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT

Catalog Number 443343

Device Problem Application Network Problem (2879)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: exempt.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd tla instrument system there was a cybersecurity breach.This is a report of a single occurrence.The following information was provided by the initial reporter: customer cybersecurity is asking to install their av on the new scu as they mentioned that in 2020 a breach happened though our system which was not detected by cylance.Customer cybersecurity mentioned that bd agreed to install their av everywhere, however, there appears to be a different understanding on bd side.

Manufacturer Narrative

Review has determined this complaint is not reportable and a duplicate of a not reportable complaint.This mdr is to be considered canceled.

Event Description

T was reported that while using bd tla instrument system there was a cybersecurity breach.This is a report of a single occurrence.The following information was provided by the initial reporter: customer cybersecurity is asking to install their av on the new scu as they mentioned that in 2020 a breach happened though our system which was not detected by cylance.Customer cybersecurity mentioned that bd agreed to install their av everywhere, however, there appears to be a different understanding on bd side.

• Brand Name: BD TLA INSTRUMENT SYSTEM
• Type of Device: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15054184
• MDR Text Key: 302002670
• Report Number: 1119779-2022-01006
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904433437
• UDI-Public: 382904433437
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1